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Randomized Controlled Trial
. 2024 Apr 16;149(16):1241-1253.
doi: 10.1161/CIRCULATIONAHA.123.065277. Epub 2024 Apr 10.

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization

Matthew T Menard #  1 , Alik Farber #  2 , Richard J Powell  3 , Kenneth Rosenfield  4 , Michael S Conte  5 , Taye H Hamza  6 , John A Kaufman  7 , Mark J Cziraky  6 , Mark A Creager  3 , Michael D Dake  8 , Michael R Jaff  9 , Diane Reid  10 , George Sopko  10 , Christopher J White  11 , Michael B Strong  1 , Max van Over  6 , Emiliano Chisci  12 , Philip P Goodney  3 , Bruce Gray  13 , Ahmed Kayssi  14 , Jeffrey J Siracuse  2 , Niteesh K Choudhry  15 ; BEST-CLI Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization

Matthew T Menard et al. Circulation. .

Abstract

Background: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL).

Methods: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression.

Results: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure.

Conclusions: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Keywords: critical limb-threatening ischemia; minimal clinically important difference; peripheral arterial disease; quality of life; randomized controlled trial; saphenous vein.

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Conflict of interest statement

Disclosures M.T.M. is an advisor to Janssen. A.F. is an advisor to Sanifit. K.R. receives income as a consultant or member of a scientific advisory board for the following entities: Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, InspireMD, Janssen/Johnson and Johnson, Magneto, Mayo Clinic, MedAlliance, Medtronic, Neptune Medical, Penumbra, Philips, Surmodics, Terumo, Thrombolex, Truvic, Vasorum, and Vumedi. K.R. owns equity or stock options in the following entities: Access Vascular, Aerami, Althea Medical, Auxetics, Contego, Crossliner, Cruzar Systems, Endospan, Imperative Care/Truvic, Innova Vascular, InspireMD, JanaCare, Magneto, MedAlliance, Neptune Medical, Orchestra, Prosomnus, Shockwave, Skydance, Summa Therapeutics, Thrombolex, Vasorum, and Vumedi. K.R. or his institution (on his behalf) receives research grants from the following entities: National Institutes of Health, Abiomed, Boston Scientific, Novo Nordisk Foundation, Penumbra, and Gettinge-Atrium. K.R. serves as a member of the board of directors of the National Pulmonary Embolism Response Team Consortium. M.S.C. is a Data Safety Monitoring Board member for an Abbott Vascular Clinical Trial. J.J.S. received an education grant from WL Gore paid to Boston University and an education grant from Becton Dickinson paid to Boston University. M.D.D. is a consultant for Cook Medical, WL Gore, and Boston Scientific. M.R.J. is a part-time employee for Boston Scientific. B.G. is a consultant to Surmodics and Hart Clinical Consultants. J.A.K. was a consultant and speaker for Cook Medical during the time of the study. The other authors report no conflicts.

Figures

Figure 1:
Figure 1:
Least Square Means and 95% Confidence Interval of QoL Outcomes, Cohort 1
Figure 1:
Figure 1:
Least Square Means and 95% Confidence Interval of QoL Outcomes, Cohort 1
Figure 1:
Figure 1:
Least Square Means and 95% Confidence Interval of QoL Outcomes, Cohort 1
Figure 2:
Figure 2:
Subgroup analysis of VascuQoL at 12 months, Cohort 1
Figure 3:
Figure 3:
Least Square Means and 95% Confidence Interval of QoL Outcomes, Cohort 2
Figure 3:
Figure 3:
Least Square Means and 95% Confidence Interval of QoL Outcomes, Cohort 2
Figure 3:
Figure 3:
Least Square Means and 95% Confidence Interval of QoL Outcomes, Cohort 2
See this image and copyright information in PMC

Comment in

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